Hair ThinningNCT06579742
A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin
A study testing Live Conscious Beyond Collagen in people with Hair Thinning and Hair Loss, run by Scale Media Inc at 1 site in United States.
Trial summary
This is a triple-blinded, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Scale Media's Live Conscious Beyond Collagen supplement on overall hair and skin health. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning, Hair Loss
- What is being tested?
- Live Conscious Beyond Collagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male
- Self-perceived hair thinning, specifically on the top and crown of the scalp for at least three months
- Self-perceived increased hair shedding for at least three months
- Concerns regarding skin health and appearance
- Has been using the same hair care routine and products for at least one month prior to the study, i.e., shampoo, conditioner, and products
- Has been using the same skincare routine and products for at least one month prior to the study, i.e., moisturizer, serums, etc.
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- Willing to maintain the same hair care routine and products throughout the study
- Willing to maintain the same skincare routine and products throughout the study
- Willing to maintain the same diet and exercise regimen during the study
- Willing to refrain from taking any vitamins, minerals, or herbal supplements that target hair growth or skin health during the study
- Willing to refrain from taking any new vitamins, minerals, or supplements of any kind during the study
- Willing to avoid introducing any new prescription medications or supplements that target hair health and appearance of skin health and appearance during the study
- Be generally healthy and do not live with any uncontrolled chronic disease
- Willing to stop taking any other multivitamin supplements at least one month prior to and for the entire study duration
- Willing to avoid dyeing the hair for the duration of the study
- Living with someone who can take their study photos for the duration of the study
Who cannot join
- Anyone with a diagnosed hair loss or hair thinning health condition, except for female pattern baldness (e.g., alopecia areata)
- Women who are pregnant, breastfeeding, or trying to conceive
- Anyone currently taking iron supplements
- Anyone unwilling or unable to follow the study protocol
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone who does not consume animal products for personal or religious reasons
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- Is undergoing or planning to undergo laboratory testing and/or significant medical procedures during the study duration
- A history of severe allergic reactions, including but not limited to any of the product's ingredients
- Has undergone any chemical treatments to the hair in the last three months, e.g., chemical straightening, hair extensions with chemical bonding, perms, and relaxers
- Has any planned chemical treatments for the hair during the study period, e.g., chemical straightening, hair extensions with chemical bonding, perms, and relaxers
- Has any planned cosmetic treatments to the face, including botox, dermal filler, chemical peels, etc.
- Currently undergoing hair loss treatment, including mechanical scalp stimulation, or has done so in the last three months
- Currently using other hair growth/thickening products
- Currently taking any prescription medication for hair loss, or has done so in the last three months
- Currently taking any prescription medication for skin health, or has done so in the last three months
- Has undergone any surgeries or invasive treatments in the last six months
- Has had any major illness in the last three months
- Currently taking medication that has hair loss as a known or observed side effect
- Currently undergoing or have you recently undergone chemotherapy or radiotherapy
- Anyone who has had a hair transplant within the last year
Trial locations and contacts
1 site in 1 country.
About this study
This is a triple-blinded, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Scale Media's Live Conscious Beyond Collagen supplement on overall hair and skin health. The study will involve 50 male or female participants aged 40 and over who have self-perceived hair thinning and shedding. The trial will last for 24 weeks and includes the completion of questionnaires and photo submissions at specific time points.
- Conditions
- Hair Thinning, Hair Loss
- Being tested
- Live Conscious Beyond Collagen, Placebo
- Keywords
- Skin Aging, Loss of Skin Elasticity, Skin Health, Hair Health
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Conscious Beyond CollagenDietary supplement
Participants in the experimental arm will take 1 scoop (10.4 g) of Live Conscious Beyond Collagen supplement mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks.
PlaceboDietary supplement
Participants in the placebo comparator arm will take 1 scoop (10.4 g) of the placebo product (Maltodextrin) mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Live Conscious Beyond Collagen Supplement | Experimental | Participants in this arm will receive the Live Conscious Beyond Collagen supplement. The supplement contains Vitamin C (90 mg), Biotin (2500 mcg), and a Proprietary Collagen Blend (10.1 g) including Types I \& III Bovine Collagen, Type II Marine Collagen, Type II Chicken Sternum Collagen, and Types I, V \& X Eggshell Membrane Collagen. Receives: Dietary Supplement: Live Conscious Beyond Collagen |
| Placebo | Placebo comparator | Participants in this arm will receive a placebo product. The placebo contains Maltodextrin. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair Density and Hair Volume
Hair health will be assessed through expert dermatologist grading and participant questionnaires to measure changes in hair density and hair volume over the course of the study.
Measured: Baseline, Month 3, and Month 6
Secondary outcomes (1)
Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity)
Skin health will be evaluated using participant self-reported questionnaires and expert dermatologist grading to assess changes in fine lines, wrinkles, skin texture, elasticity, brightness, radiance, firmness, and roughness over the course of the study.
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start7 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scale Media Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579742
- Sponsor's protocol ID
- 20423
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Examine the Efficacy of a Supplement to Support Healthy Hair and Skin
- ClinicalTrials.gov ID
- NCT06579742
- Acronym / sponsor ID
- 20423
- Conditions
- Hair Thinning, Hair Loss
- Keywords
- Skin Aging, Loss of Skin Elasticity, Skin Health, Hair Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Scale Media IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a triple-blinded, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Scale Media's Live Conscious Beyond Collagen supplement on overall hair and skin health. The study will involve 50 male or female participants aged 40 and over who have self-perceived hair thinning and shedding. The trial will last for 24 weeks and includes the completion of questionnaires and photo submissions at specific time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Conscious Beyond Collagen Supplement | Experimental | Dietary Supplement: Live Conscious Beyond CollagenParticipants in this arm will receive the Live Conscious Beyond Collagen supplement. The supplement contains Vitamin C (90 mg), Biotin (2500 mcg), and a Proprietary Collagen Blend (10.1 g) including Types I \& III Bovine Collagen, Type II Marine Collagen, Type II Chicken Sternum Collagen, and Types I, V \& X Eggshell Membrane Collagen. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive a placebo product. The placebo contains Maltodextrin. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female or male
- Self-perceived hair thinning, specifically on the top and crown of the scalp for at least three months
- Self-perceived increased hair shedding for at least three months
- Concerns regarding skin health and appearance
- Has been using the same hair care routine and products for at least one month prior to the study, i.e., shampoo, conditioner, and products
Key exclusion criteria (20 listed)
- Anyone with a diagnosed hair loss or hair thinning health condition, except for female pattern baldness (e.g., alopecia areata)
- Women who are pregnant, breastfeeding, or trying to conceive
- Anyone currently taking iron supplements
- Anyone unwilling or unable to follow the study protocol
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Conscious Beyond CollagenParticipants in the experimental arm will take 1 scoop (10.4 g) of Live Conscious Beyond Collagen supplement mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks. | Dietary supplement | Live Conscious Beyond Collagen Supplement |
| PlaceboParticipants in the placebo comparator arm will take 1 scoop (10.4 g) of the placebo product (Maltodextrin) mixed with 12 fl oz of water in the evening after their last meal of the day for 24 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in Hair Density and Hair Volume
Time frame: Baseline, Month 3, and Month 6
Hair health will be assessed through expert dermatologist grading and participant questionnaires to measure changes in hair density and hair volume over the course of the study.
1 secondary outcome
Change in Skin Health (Fine Lines, Wrinkles, Texture, and Elasticity)
Time frame: Baseline, Month 3, and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Conscious Beyond Collagen in people with Hair Thinning and Hair Loss, run by Scale Media Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hair Density and Hair Volume (time frame: Baseline, Month 3, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.